efficacy study of condrosulf in the treatment of symptomatic oa of the hand

Conditions: Osteoarthrosis

Summary: the goal of the present study is to investigate the effectiveness of condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis. primary endpoints of the study are the evaluation of global spontaneous pain (huskisson's visual analogue scale: vas) and the score of dreiser's algo-functional index (fihoa) during the treatment with the tested product, condrosulf®, versus placebo.

the goal of the present study is to investigate the effectiveness of condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients. primary endpoints: primary endpoints of the study are the evaluation of global spontaneous pain (huskisson's visual analogue scale: vas) and the score of dreiser's algo-functional index (fihoa) during the treatment with the tested product, condrosulf®, versus placebo. secondary endpoints are: efficacy evaluation: global impression of efficacy expressed by the patient and the physician (vas), grip strength (measured manometrically); morning stiffness duration; consumption of paracetamol; tolerability (4-point verbal scale); adverse events occurring during the treatment period; other parameters:treatment compliance; biological markers of arthritis

Eligibility criteria:
inclusion criteria: * patients of either sex * aged 40 and over * outpatients * patients fulfilling the american congress of rheumatology (acr) criteria for the reporting of hand oa * patients showing x-ray features of hand oa on at least two joints (2 ip and/or 1 ip and 1 tmc) of the dominant hand on standard plain radiographs (\< 6 month). * suffering from regular spontaneous pain on the dominant hand (vas \> or = 40 mm at inclusion time). * showing a fihoa score \> or = 6. * having had at least two painful flares in a finger joint during the previous 12 month. * patients who have signed the written informed consent for their participation in the study * patients able to understand and follow the protocol. * patients with a satisfying health and nutritional status. * female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation). * female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study. exclusion criteria: * inflammatory joint disease of other origin * septic arthritis * chronic inflammatory joint disease * previous articular fracture of the concerned articulations * use of analgesic therapy for other indications * receiving oral corticosteroids * mono-articular posttraumatic oa of the finger * planning surgery of the hands in the following 6 months * patients suffering or having suffered from secondary osteoarthritis after one of the following diseases: * infectious arthritis - acromegaly * ochronosis - hemachromatosis * gout - wilson's disease * chondrocalcinosis - paget's disease * osteochondrosis - mutation of collagen * genetic problems (for ex. hypermobility) - previous joint fracture * arthropathies of different aetiologies - algodystrophy (m. sudeck) * congenital abnormalities * recurrent pseudogout * major dysplasias * intra-articular injection in a hand joint from less than 3 months * basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months * articular lavage in the last 3 months * treatment with corticoids, by any administration route during the last month * patient suffering from frequent asthma crises * physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year * serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection * participation in other clinical trials in the two months preceding the study * known or ascertained hypersensitivity to the active ingredient of the tested drug. * patients refusing to sign the written informed consent form * patients who do not co-operate, not respecting the protocol requirements * pregnant or lactating women

Keywords: symptomatic oa of the hand